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Renal ImpairmentNCT04273230

Kidney Affection in Non Alcaholic Fatty Liver Diseases

An observational study of Renal Impairment, run by Assiut University at 2 sites in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Early detection of renal affection in patients with non alcaholic fatty liver diseases using microalbuminuria. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Renal Impairment
What is being tested?
Microalbuminuria detection
How many people
114 participants
Where
2 sitesEgypt
Study dates
1 Mar 2020to 1 Jun 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Adult, Older adult

Study population: All pateints with fatty liver diseases diagnosed by ultrasonography and lab investigation

Who may be able to join

  • All patients with fatty liver disease diagnosed by abdominal ultrasonogarphy .
  • All patients with fatty liver disease diagnosed by lab investigations.

Who cannot join

  • Diabetic patients
  • Hypertensive patients
  • patients with chronic kidney disesase
  • patient with systemic diseases or chronic liver diseases affecting kidneys.

Trial locations and contacts

2 sites in 1 country.

Egypt2 sites
  • Assiut university

    Asyut

  • AssiutU

    Asyut

Other trials in Egypt

About this study

Official title: Early Detection of Kidney Affection in Non Alcaholic Fatty Liver Diseases(NAFLD)

Early detection of renal affection in patients with non alcaholic fatty liver diseases using microalbuminuria.

Read the detailed description

With the increasing prevalence of obesity, diabetes mellitus and the metabolic syndrome in the general population, non-alcoholic fatty liver disease (NAFLD) has become the most common cause of chronic liver disease. NAFLD refers to a wide spectrum of liver damage, ranging from simple steatosis to non-alcoholic steatohepatitis, advanced fibrosis and cirrhosis as well hepatocellular carcinoma.

Several large cross-sectional population and hospital-based studies involving both diabetic patients and patients without diabetes have consistently shown that the prevalence of CKD is increased in people with NAFLD . NAFLD and CKD share some common features, including visceral obesity,T2DM, hypertension and metabolic syndrome . The possible link between NAFLD and CKD has recently attracted considerable scientific interest. Establishing a link between liver and kidney injury would enhance the earlier identification of kidney disease and allow for the selection of treatments targeting both liver and kidney disease with potentially relevant preventive and therapeutic implications . The ultimate goal of identifying patients with established but also with early kidney damage is to prevent disease progression and minimize complications, to promote quality of life and improve survival .

Many recent studies, including the meta-analysis from Musso et al. suggest that individuals with NAFLD should be screened for CKD by estimation of GFR and urinalysis even in the absence of classical risk factors for CKD, particularly if NASH and/or advanced fibrosis are suspected . Early recognition of impaired kidney function in patients with NAFLD, may also allow drug dosage adjustment, thus preventing drug accumulation especially in those being treated for obesity associated co-morbidities.

Chronic kidney disease (CKD) is defined by the presence of reduced glomerular filtration rate (GFR <60 mL/min/1.73 m2)and/or evidence of kidney damage (usually indicated by albuminuria or proteinuria) for 3 or more months . On the other hand kidney failure is defined as a GFR of less than 15 mL/min per 1.73 m2,or the need for treatment with dialysis or transplantation . In clinical practice the most common tests for CKD diagnosis include eGFR estimated from the serum creatinine concentration and albuminuria from the urinary albumin-to-creatinine ratio (ACR). The importance of eGFR and albuminuria as diagnostic tools becomes obvious by their use in classification of CKD patients in stages .On the basis of GFR the disease is classified into five stages:more than 90 mL/min per 1.73 m2(stage 1), 60-89 mL/min per1.73 m2(stage 2), 30-59 mL/min per 1.73 m2(stage 3), more specific 45-59 mL/min per 1.73 m2(stage 3a) and 30-44 mL/min per1.73 m2(stage 3b), 15-29 mL/min per 1.73 m2(stage 4) and less than 15 mL/min per 1.73 m2(stage 5) .

Albuminuria as a marker of kidney damage is characterized by increased glomerular permeability and urine ACR > 30 mg/g. The normal urinary ACR in young adults is <10 mg/g. Urine ACR categories 10-29, 30-300and >300 mg are high normal, high, and very high, respectively.Urine ACR >2000 mg/g is accompanied by signs and symptoms of nephrotic syndrome (low serum albumin, edema, and high serum cholesterol)

Being tested
Microalbuminuria detection
Medical subject headings
Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Microalbuminuria detectionOther

    Detection of microalbumin in urine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Early detection of kidney affection in non alcaholic fatty liver diseases

    Finding patients with non alcaholic fatty liver diseases who develop renal impairment

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2020
  2. Study start1 Mar 2020
  3. Primary completion1 Mar 2021
  4. Study completion1 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
114 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04273230
Sponsor's protocol ID
Kidney affection in NAFLD
Status last verified
Feb 2020
First submitted
14 Feb 2020
Last updated
23 Feb 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Arase Y, Suzuki F, Kobayashi M, Suzuki Y, Kawamura Y, Matsumoto N, Akuta N, Kobayashi M, Sezaki H, Saito S, Hosaka T, Ikeda K, Kumada H, Ohmoto Y, Amakawa K, Tsuji H, Hsieh SD, Kato K, Tanabe M, Ogawa K, Hara S, Kobayashi T. The development of chronic kidney disease in Japanese patients with non-alcoholic fatty liver disease. Intern Med. 2011;50(10):1081-7. doi: 10.2169/internalmedicine.50.5043. Epub 2011 May 1.

    PubMed 21576832
  • Kiapidou S, Liava C, Kalogirou M, Akriviadis E, Sinakos E. Chronic kidney disease in patients with non-alcoholic fatty liver disease: What the Hepatologist should know? Ann Hepatol. 2020 Mar-Apr;19(2):134-144. doi: 10.1016/j.aohep.2019.07.013. Epub 2019 Sep 23.

    PubMed 31606352
  • Park H, Dawwas GK, Liu X, Nguyen MH. Nonalcoholic fatty liver disease increases risk of incident advanced chronic kidney disease: a propensity-matched cohort study. J Intern Med. 2019 Dec;286(6):711-722. doi: 10.1111/joim.12964. Epub 2019 Aug 23.

    PubMed 31359543

Questions about this trial

What is this clinical trial studying?

An observational study of Renal Impairment, run by Assiut University at 2 sites in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Early detection of kidney affection in non alcaholic fatty liver diseases (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04273230, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2022.

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